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Docetaxel in Treating Patients With Advanced Cancer of the Cervix

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003445
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: September 2001
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients with advanced cancer of the cervix.


Condition Intervention Phase
Cervical Cancer
 Drug: docetaxel
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy With Docetaxel in Advanced Cervical Carcinoma

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1997
Detailed Description:

OBJECTIVES: I. Assess the antitumor activity of docetaxel as neoadjuvant chemotherapy in patients with locally advanced squamous cell carcinoma of the cervix. II. Assess the tumor response, toxic effect, and survival rate of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Treatment is repeated every 3 weeks for 3 courses. Patients are followed every 3 months posttreatment.

PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven stage IIB, IIIA, IIIB, and IVA squamous cell carcinoma of the cervix Bidimensionally measurable disease No bilateral hydronefrosis

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL Leukocytes at least 4,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) AST less than 1.25 times ULN Renal: BUN less than 30 mg/dL AND Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No prior or other concurrent malignancies, other than properly treated basal cell skin cancer

PRIOR CONCURRENT THERAPY: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003445

Locations
Argentina
Unidad Oncologica Del Comahue
Neuquen, Argentina, 8300
Sponsors and Collaborators
Grupo Oncologico Cooperativo del Sur
Investigators
Study Chair: Carlos Teodoro Vallejo, MD Grupo Oncologico Cooperativo del Sur
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00003445     History of Changes
Other Study ID Numbers: CDR0000066473, GOCS-04-CC-97, NCI-V98-1456
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III cervical cancer
stage IIB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013